The Impact of Early Palliative Care on the Quality of Life of Patients With Advanced Pancreas Cancer: A Case-crossover Study

This is a prospective case-crossover study of patients with advanced pancreatic cancer (APC) at CancerCare Manitoba (CCMB) with early palliative care (PALC) plus standard oncologic care.

The primary endpoint of this study is quality of life (QOL) at week 16, measured by the Functional Assessment of Cancer Therapy - hepatobiliary (FACT-Hep). FACT-hep is a 45-item tool, which measures physical, emotional, social and functional well-being, and has been validated in a general population with hepatobiliary cancers, including metastatic pancreatic cancer. FACT-Hep has strong psychometric properties, and is a reliable, comprehensive and well-validated scale for use in patients with gastrointestinal cancers.

Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised Edmonton Symptom Assessment Scale (ESAS-r), (a widely used and validated tool to assess symptom intensity, which is routinely completed by patients at all CCMB visits); (2) depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS), (a-14 item scale which can be used in the outpatient setting to screen for anxiety and depression within the previous week) and the Patient Health Questionnaire (PHQ-9), (a sensitive (88%) and specific (88%) 9-question tool which incorporates diagnostic criteria for major depression); and overall survival measured from date of registration to death.

Recruitment to the study will occur in a clinic staffed by medical oncologists with expertise in gastrointestinal cancers, as this is the first point of entry into the CCMB system for patients with APC.

Early PALC will consist of referral to PALC at the time of study enrollment. Patients will undergo an initial consultation by the PALC team within two weeks of registration. Patients enrolled in the study who are also receiving chemotherapy must have their initial PALC consultation before receiving cycle 2 of chemotherapy. Baseline QoL questionnaires may be completed any time between registration and the first PALC consultation. The PALC team will be led by a physician with subspecialty training in PALC and an advanced practice nurse, with the ability to involve other members of the team (dietician, pharmacist, social worker, psychologist, psychiatrist, spiritual care, home care) as needed. The initial consultation by the PALC team will consist of assessments as per guidelines set by the Canadian Hospice Palliative Care Association. Patients will be followed by the PALC team at least every 2 weeks for the first month, then every 4 weeks until week 16, then at the discretion of the PALC team thereafter. Follow-up PALC visits will occur in person or via telehealth videoconference. A more intensive follow up regimen will occur early on, with a goal of achieving symptom control, as APC related symptoms can result in emergency room visits and hospitalizations. Patients will also receive regular oncologic follow up as directed by their oncologist.